Translation of Lifestyle Modification Programs Focused on Physical Activity and Dietary Habits Delivered in Community Settings

Lifestyle modification programs (LMPs) can provide individuals with behavioral skills to sustain long-term changes to their physical activity (PA) levels and dietary habits. Yet, there is much work to be done in the translation of these programs to community settings. This review identified LMPs that focused on changing both PA and dietary behaviors and examined common features and barriers faced in their translation to community settings. A search of multiple online databases was conducted to identify LMPs that included participants over the age of 18 who enrolled in LMPs, offered in community settings, and had the goal of improving both PA and dietary behaviors. Data were extracted on participant demographics, study design characteristics, and study outcome variables including changes in PA, dietary habits, body weight, and clinical outcomes. We identified 27 studies that met inclusion criteria. Despite high levels of retention and adherence to the interventions, varying levels of success were observed in increasing PA levels, improving dietary habits, reducing body weight, and improving clinic outcomes. LMPs addressing issues of PA and dietary habits can be successfully implemented in a community setting. However, inconsistent reporting of key components in the translation of these studies (participant recruitment, utilization of behavioral strategies) may limit their replication and advancement of future programs. Future efforts should better address issues such as identifying barriers to participation and program implementation, utilization of community resources, and evaluating changes across multiple health behaviors

Cardiovascular Efficacy and Safety of Bococizumab in High-Risk Patients

Bococizumab is a humanized monoclonal antibody that inhibits proprotein convertase subtilisin- kexin type 9 (PCSK9) and reduces levels of low-density lipoprotein (LDL) cholesterol. We sought to evaluate the efficacy of bococizumab in patients at high cardiovascular risk. METHODS In two parallel, multinational trials with different entry criteria for LDL cholesterol levels, we randomly assigned the 27,438 patients in the combined trials to receive bococizumab (at a dose of 150 mg) subcutaneously every 2 weeks or placebo. The primary end point was nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina requiring urgent revascularization, or cardiovascular death; 93% of the patients were receiving statin therapy at baseline. The trials were stopped early after the sponsor elected to discontinue the development of bococizumab owing in part to the development of high rates of antidrug antibodies, as seen in data from other studies in the program. The median follow-up was 10 months. RESULTS At 14 weeks, patients in the combined trials had a mean change from baseline in LDL cholesterol levels of -56.0% in the bococizumab group and +2.9% in the placebo group, for a between-group difference of -59.0 percentage points (P<0.001) and a median reduction from baseline of 64.2% (P<0.001). In the lower-risk, shorter-duration trial (in which the patients had a baseline LDL cholesterol level of ≥70 mg per deciliter [1.8 mmol per liter] and the median follow-up was 7 months), major cardiovascular events occurred in 173 patients each in the bococizumab group and the placebo group (hazard ratio, 0.99; 95% confidence interval [CI], 0.80 to 1.22; P = 0.94). In the higher-risk, longer-duration trial (in which the patients had a baseline LDL cholesterol level of ≥100 mg per deciliter [2.6 mmol per liter] and the median follow-up was 12 months), major cardiovascular events occurred in 179 and 224 patients, respectively (hazard ratio, 0.79; 95% CI, 0.65 to 0.97; P = 0.02). The hazard ratio for the primary end point in the combined trials was 0.88 (95% CI, 0.76 to 1.02; P = 0.08). Injection-site reactions were more common in the bococizumab group than in the placebo group (10.4% vs. 1.3%, P<0.001). CONCLUSIONS In two randomized trials comparing the PCSK9 inhibitor bococizumab with placebo, bococizumab had no benefit with respect to major adverse cardiovascular events in the trial involving lower-risk patients but did have a significant benefit in the trial involving higher-risk patients